Systematic review of systemic sclerosis-specific instruments for the EULAR Outcome Measures Library: An evolutional database model of validated patient-reported outcomes
- Ingegnoli, F., Carmona, L., and Castrejon, I.
- OBJECTIVES: The EULAR Outcome Measures Library (OML) is a freely available database of validated patient-reported outcomes (PROs). The aim of this study was to provide a comprehensive review of validated PROs specifically developed for systemic sclerosis (SSc) to feed the EULAR OML.
METHODS: A sensitive search was developed in Medline and Embase to identify all validation studies, cohort studies, reviews, or meta-analyses in which the objective were the development or validation of specific PROs evaluating organ involvement, disease activity or damage in SSc. A reviewer screened title and abstracts, selected the studies, and collected data concerning validation using ad hoc forms based on the COSMIN checklist.
RESULTS: From 13,140 articles captured, 74 met the predefined criteria. After excluding two instruments as they were unavailable in English the selected 23 studies provided information on seven SSc-specific PROs on different SSc domains: burden of illness (symptom burden index), functional status (Scleroderma Assessment Questionnaire), functional ability (scleroderma Functional Score), Raynaud's phenomenon (Raynaud's condition score), mouth involvement (Mouth Handicap in SSc), gastro-intestinal involvement (University of California Los Angeles-Scleroderma Clinical Trial Consortium Gastro-Intestinal tract 2.0), and skin involvement (skin self-assessment). Each of them is partially validated and has different psychometric requirements.
CONCLUSIONS: Seven SSc-specific PROs have a minimum validation and were included in the EULAR OML. Further development in the area of disease-specific PROs in SSc is warranted.
- Semin Arthritis Rheum
- Publication year:
- Symptom status:
- Emotional state
- Functional status:
- Physical functioning
- Adults (18-65)
- Diseases of and symptoms related to the musculoskeletal system and connective tissue
- PRO / non-PRO:
- Patient Reported Outcome
- Type of measurement instrument:
- 1 - Questionnaires
- FS - scleroderma Functional Score
MHISS - Mouth Handicap in Systemic Sclerosis
RCS - Raynaud's Condition Score
SAQ - Scleroderma Assessment Questionnaire
SBI - Symptom Burden Index
Skin Self-Assessment Questionnaire
UCLA-SCTC-GIT-2.0 - University of California, LosAngeles, Scleroderma Clinical Trial Consortium Gastro Intestinal Tract 2.0